Pancreatic cancer
Conditions
Interventions
Experimental Group:Combination of Iparomlimab and Tuvonralimab with Irinotecan Hydrochloride Liposome Injection (II) and 5-FU/LV
Sponsors
Harbin medical university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 75 years old, gender not limited. 2. Pancreatic cancer confirmed histologically or cytologically, unresectable locally advanced or metastatic disease; 3. Disease progression after first-line treatment (excluding irinotecan); 4. Confirmed to have at least one measurable lesion in accordance with RECIST 1.1 standards; 5.ECOG score: 0-1 point; 6. Expected survival period >=12 weeks; 7. Normal function of major organs, that is, meeting the following criteria (within 14 days before enrollment) : ANC>1.5 x 10^9/L, platelet >100 x 10^9/L, hemoglobin >100g/L, serum bilirubin 60 mL/min; 8. Voluntarily sign the informed consent form and be able to understand and comply with the research requirements to complete the study.
Exclusion criteria
Exclusion criteria: 1.Known allergies to research drugs or any of their excipients; 2.The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 level evaluation = 1 (excluding toxicity judged by researchers to have no safety risks such as hair loss); 3.Suffering from other malignant tumors in the past 5 years, except for those that have been cured; 4.Active central nervous system metastasis; 5.Merge with other serious illnesses, such as extensive interstitial pneumonia requiring drug treatment, active or uncontrolled infections (tuberculosis, HIV, etc.), decompensated liver disease, active hepatitis, and active bleeding; Patients with cerebrovascular accidents or pulmonary embolism; Active, known or suspected autoimmune diseases; Has an active infection and currently requires systemic anti infective treatment; 6.There is subclinical pancreatitis that meets the diagnostic criteria for acute pancreatitis or requires recent intervention; 7.Pregnant, preconception, and lactating women; 8.Other situations that researchers believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;6-month progression free survival rate;objective response rate;3-month progression free survival rate;Time To Treatment Failure;6-month OS rate;Incidence of immune related adverse events(irAEs);Overall survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhiwei Li
Harbin medical university cancer hospital
Outcome results
None listed